GSK plc GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk profile of the Blenrep (belantamab mafodotin-blmf) combination therapy at the proposed dosing regimen.

The latest inspection comes 2 1/2 years after the agency allowed Sun Pharma to keep shipping some drugs to Americans even after banning the factory from the U.S. market because of quality problems.

A recall of thousands of cases of fruits and vegetables has been issued due to potential fluid contamination—the second-highest risk warning given by the FDA.

The culture of academic medicine needs to change, FDA Commissioner Marty Makary, MD, MPH, said at an event sponsored by The Hill.

The FDA has declined to approve Columvi, in combination with the chemo regimen GemOx, for the treatment of second-line DLBCL patients who are not eligible for autologous stem cell transplant, Roche and its subsidiary Genentech said Friday.

The United States Food and Drug Administration (FDA) announced on May 22 that certain frozen, raw and half-shell oysters from South Korea could be infected with norovirus.. According to a news ...

The comeback story of belantamab mafodotin (Blenrep) hit a roadblock Thursday as the FDA's Oncologic Drugs Advisory Committee (ODAC) voted that the drug does not have a favorable benefit-risk profile in combination with either of two different regimens for patients with relapsed and refractory multiple myeloma.